1. Field of the Invention
This invention relates generally to a method and apparatus for improving a surgical procedure wherein staples are used to create an anastomosis or for closing the margins following removal of diseased tissue, and more particularly to an apparatus for reinforcing the staple line to prevent subsequent tearing of the tissue of fluid leakage, or, in the case of a pneumectomy, air leakage.
2. Discussion of the Prior Art
A frequent and troublesome complication following volume reduction surgery or other surgery performed on the lungs of patients suffering from bullous emphysema has been persistent air leaks which routinely occur and often last for several weeks. Even the smallest pinhole leak in lung tissue can result in a significant and prolonged air loss. In performing lung volume reduction surgery to improve the respiratory mechanics, a linear surgical stapler is often used to first place a plurality of staggered rows of closely spaced staples through the lung tissue at the margin between healthy and diseased tissue. The lung is then trimmed away along the outermost staple line or by dividing the tissue between staple lines. When using this procedure, and upon inflation of the lung, air leakage tends to occur not from the cut surface of the lung, but from the staple holes themselves which, being placed in severely emphysematous lung tissue, expand or tear as the lung is reinflated.
In the case of giant bullae, surgeons have previously utilized the averted wall of the incised bullae to reinforce the base of the staple line. This procedure is reported in a paper by J. D. Cooper, et al. entitled "Median Sternotomy for Bilateral Resection of Emphysematous Bullae" appearing in the Journal of Thoracic Cardiovascular Surgery in 1981, Vol. 82, pp. 892-897. Because the pathologic condition for which the volume reduction surgery is being performed seldom includes such giant bullae, a search continued for a suitable material for reinforcing the staple lines. Juettner and colleagues described use of a polydioxanone ribbon in conjunction with a TA type of stapling device. Here, reference is made to a paper captioned "Reinforced Staple Line in Severely Emphysematous Lungs", J. Thorac. Cardiovasc. Surg., 1989: 97: 362-3. While the approach described therein works fairly well, the ribbon material does not cut easily with the knife embodied in the surgical stapler nor is it suitable for overlapping staple lines.
R. M. Peters reports in the J. Thorac. Cardiovasc. Surg., 1989: 97: 361, the use of thin Teflon.RTM. felt, attached to the stapling device with adhesive strips. T. Nakamura et al. describe the use of a non-woven fabric of polyglycolic acid as a pledget for closing the bronchial stump, and as a patch for manually oversewing lung resection margins, Japan Lung Surg. J., 1992: 40: (10) 1826.
The present invention is concerned with an improved article for use with a surgical staple gun for effectively reinforcing staple lines following removal of diseased tissue that not only reduce the incidence of tearing of the tissue at the staple line, but also, in the case of lung reduction surgery, greatly reduces the incidence of post-operative air leakage along the staples used to close the margins following removal of diseased lung tissue. While use of the present invention is being explained using lung surgery as the environment, the article of the present invention may also be used with staple guns having non-linear jaws, such as those designed to join bowel segments to preclude leakage.